Avenda Well being receives FDA clearance for AI assist software program for prostate most cancers

Avenda Well being obtained FDA 510(ok) clearance for AI-backed medical choice assist software program that assists physicians in prostate most cancers care.

iQuest, which formally obtained the company inexperienced gentle late final month, is supposed for use alongside MRI and biopsy outcomes. The system makes use of particular affected person knowledge and deep studying to construct a “tailor-made map” exhibiting the place most cancers is positioned within the prostate. 

Based on the 510(ok), the software helps physicians phase MRI  options, consider lesions and plan forward for surgical procedures and biopsies. Avenda pitches the software as a solution to reduce the chance of lowered sexual or urinary operate after remedy.

“We’re excited concerning the potential to unlock precision care in prostate most cancers with iQuest, as it’s a key enabling expertise for focal remedy to be a actuality for urologists and sufferers,” stated Dr. Shyam Natarajan, cofounder and CEO of Avenda Well being. “To ensure that a health care provider to deal with focally, they should know the place most cancers is and the wholesome tissue to keep away from. That is very important data that iQuest now gives. This can be a large step ahead in reworking the usual of care in prostate most cancers and brings us that a lot nearer to providing efficient remedy that preserves high quality of life to suppliers and sufferers throughout the U.S.”

THE LARGER TREND

The clearance marks the second 510(ok) for Avenda, which was spun out from UCLA in 2017. The corporate first obtained FDA clearance for a focal laser ablation system in 2020.

Earlier this yr, Avenda raised $10 million in a Sequence B funding spherical led by VCapital. The corporate additionally introduced it had obtained an investigational system exemption (IDE) from the FDA for its FocalPoint ablation system that is designed for use at the side of iQuest.

An IDE permits a tool for use in an investigational examine to gather security and effectiveness knowledge, most frequently performed to assist premarket approval for Class III medical units. In August, Avenda stated it can use the IDE to conduct a randomized managed trial to judge utilizing the 2 merchandise towards normal take care of prostate most cancers.